MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX420T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information / invstigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem(#fx420t) was implanted during a procedure performed on (b)(6) 2021 indwelled by posterior puncture.According to the complainant, the shunt system was believed to be operated in underdrainage and difficult to adjust.The patient underwent a revision procedure on (b)(6) 2021.The complainant device should be return to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6)years, height: 168 cm, weight: (b)(6) kg, gender: unknown.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: clear deposits on the entire product (signs of mold); particles in the delivery liquid.Permeability test: the test showed that the progav 2.0 shunt system is non-permeable.To determine the location of the occlusion, the shunt system was dismantled and each element was tested individually for permeability.The test showed that the ventricular catheter is permeable, while the valves and the reservoir are non-permeable.In the first moment of the test, the progav 2.0 was permeable, but after a short time the liquid was no longer drained.The investigation showed a blockage in the valves.Computer control test: the computer control test was not applicable due to the blockage determined in "permeability test." adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.Braking force and brake function test: the braking force of the progav 2.0 was within the specified tolerance and the brake function operated as expected.Internal inspection of product: in order to verify whether the investigated shunt system was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the shunt system.After dismantling of the valves, some deposits were found in both valves.In the shunt assistant we used blue contrast medium.Results: based on our investigation results, we can identify a "blockage" in the shunt system.We are assuming that the deposits detected within the valves have caused the functional impairment.The reason for complaint "difficult adjustability" was not explained to us at the time of our investigation.We could not determine deviations in adjustability.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 WITH SA20 AND DISTAL CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12666631
• Report Number: 3004721439-2021-00285
• Device Sequence Number: 1179330
• Product Code: JXG
• UDI-Device Identifier: 04041906136628
• UDI-Public: 4041906136628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2026
• Device Model Number: FX420T
• Device Catalogue Number: FX420T
• Device Lot Number: 20051097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Unknown
• Patient Weight: 62 KG